QA Manager

Location: Shanghai, China

Time Type: Full time

Job Description

Bring more to life.

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

The QA Manager for Cytiva is responsible for China localization project quality related support and manage Medical Device GSP related affairs. This position is part of the Cytiva China QA/RA located in Shanghai and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

• Manage GSP-related policy and compliance affairs for Cytiva medical devices. (i.e. Compliance with Shanghai MPA and Pudong Market Bureau requirements, Ad Promo Material filing as needed)
• Support the line manager in delivering successful localization projects from a quality perspective in China.
• Lead or contribute to post-market QA activities and internal/external audits, with a focus on driving continuous improvements such as timely delivery of CAPAs and maintaining the QMS.
• Provide and review Quality Agreements (QAA) for commercial teams and customers in a timely manner.
• Perform other quality-related duties as assigned by the manager.

The essential requirements of the job include:

• Bachelor’s degree or above in healthcare and/or Lifesciences (medical device, chemistry, biopharma, pharma…) relevant.
• 5-8 years’ experience of quality assurance and quality engineer experience. Familiar with GSP, GMP and/or ISO9001/13485 quality system requirements.
• Strong skills of problem solving.
• Have strong sense of responsibility as Quality Assurance Manager.
• Fluently communicate in English in written and/or oral.

It would be a plus if you also possess previous experience in:

• Qualified the Internal auditor of ISO9001 or ISO 13485
• Fast learner with good cross functional communication and collaboration capabilities

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.